Serialization Engineer - Packaging Operations

Contract Pharmacal Corp.; Hauppauge (NY); Hybrid; USD 75,000 - 100,000; Full time

Job summary

Contract Pharmacal Corp. is seeking a Serialization Engineer to join the Operations team in Hauppauge, NY. This hands-on role supports serialized packaging operations and regulatory compliance across pharmaceutical products from design to launch.

You will collaborate with Packaging, Quality, Engineering, and project teams, gaining experience with packaging design, commissioning, validation, and DSCSA guidelines while ensuring product integrity and consumer safety.

Qualifications

• Bachelor’s degree in a packaging/engineering field or related technical discipline required.
• Minimum 3 years of relevant experience in engineering, packaging or serialization roles.
• Hands-on experience with packaging equipment, line trials, and process validation.
• Experience with AutoCAD, MS Excel, MS Project or other engineering software.

Responsibilities

• Support serialized packaging projects from start to launch by assisting in equipment commissioning, validation, and process optimization for new and existing packaging configurations.
• Conduct line trials, studies, and assessments to determine CPPs and ensure compliant packaging operations.
• Administer serialization operations including serial number management, master recipe creation, EPCIS updates, and shipment event notifications.
• Collaborate with Packaging, Engineering, Quality, Project Management, and Business Development teams to solve technical challenges and implement process improvements.
• Develop and maintain technical documentation including SOPs, setup sheets, P&IDs, and packaging engineering reports to support compliance and operational excellence.

Skills

Pharma serialization knowledge

DSCSA guidelines

Cross-functional collaboration

Technical writing

Problem solving

Education

Bachelor's degree in Packaging Eng / Mechanical Eng / Manufacturing Eng or related field

Tools

AutoCAD

MS Excel

MS Project

Job description

Description

We are seeking a Serialization Engineer to join our Operations team, where you’ll play a key role in supporting serialized packaging operations and technical packaging solutions across pharmaceutical products. In this hands-on, cross-functional role, you’ll work closely with Packaging, Quality, Engineering, and project teams to ensure efficient, compliant, and accurate packaging operations from inception through commercial launch. This is an excellent opportunity for someone who enjoys solving technical challenges, learning new serialization technologies, and contributing directly to high-quality pharmaceutical packaging processes.

Job Type: Full-Time

Location: Hauppauge, NY

Works Hours: Monday – Friday, 9:00AM – 5:00PM

Pay Range: $75,000 - $100,000 per year, depending on experience

Start Date: ASAP

What makes this role exciting:

• Hands-on with cutting-edge serialization technology – work directly with Optel Linemaster, Pharmaproof, and other packaging automation systems.
• Learn and grow in a fast-paced pharmaceutical environment – gain exposure to packaging design, commissioning, validation, and regulatory compliance.
• Cross-functional experience – collaborate with Engineering, Quality, Project Management, and technical teams to see projects from concept to commercial launch.
• Impactful work – your contributions directly support product integrity, consumer safety, and regulatory compliance.

Why Join CPC?

At CPC, you’ll be part of a team that has set the standard in pharmaceutical development and contract manufacturing since 1971, helping bring high-quality OTC, dietary supplement, and prescription products to market faster and safer than ever. We pride ourselves on quality as a core value, innovative problem-solving, and a collaborative culture where everyone plays a role in advancing formulation and manufacturing excellence. CPC offers an inclusive, respectful workplace with opportunities to grow your skills and career while working with cutting-edge technologies and serving leading global brands. With a commitment to employee success, competitive benefits, and a culture built on teamwork and integrity, CPC is a place where your contributions truly make an impact.

Requirements

Responsibilities

In this role, you will:

• Support serialized packaging projects from start to launch by assisting in equipment commissioning, validation, and process optimization for new and existing packaging configurations.
• Conduct line trials, studies, and assessments to determine critical process parameters (CPP) and ensure consistent, compliant packaging operations.
• Administer serialization operations including serial number management, master recipe creation, EPCIS updates, and shipment event notifications.
• Collaborate cross-functionally with Packaging, Engineering, Quality, Project Management, and Business Development teams to solve technical challenges and implement process improvements.
• Develop and maintain technical documentation including SOPs, setup sheets, P&IDs, and packaging engineering reports to support compliance and operational excellence.

Education & Experience

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical discipline required
• Minimum 3 years of relevant experience in engineering, packaging or serialization roles, preferably in a pharmaceutical environment
• Hands-on experience with packaging equipment, line trials, and process validation strongly preferred
• Experience with AutoCAD, MS Excel, MS Project, or other engineering software

Skills, Knowledge & Abilities

• Knowledge of Pharmaceutical Serialization and Aggregation systems and DSCSA guidelines
• Familiarity with FDA, cGMP, and 21 CFR Part 210, 211, and Part 11
• Strong technical writing and documentation skills
• Hands-on knowledge of packaging equipment setup, operation, and maintenance
• Ability to read and develop engineering drawings, P&IDs, and technical documentation
• Strong problem-solving skills and ability to work in cross-functional teams